Flax Muffins and Cholesterol Lowering
Not Applicable
Active, not recruiting
- Conditions
- Above Optimal Plasma LDL Concentrations
- Interventions
- Other: muffin
- Registration Number
- NCT01821131
- Lead Sponsor
- St. Boniface Hospital
- Brief Summary
This Clinical Trial is being conducted to study the LDL (bad) cholesterol lowering abilities of flax. The purpose of this study is to find the lowest dose of flax that can lower LDL-cholesterol.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
- male and non-pregnant/non-lactating female
- Body mass index 18.5-40.0 kg/m2
- Fasting plasma LDL cholesterol 2.6-5.0 mmol/L
- Regular dietary habits (ie. breakfast, lunch and dinner meals consumed daily)
- Willing to comply with protocol requirements
- Willing to provide informed consent
Exclusion Criteria
- Medical history of cardiovascular disease, use of cholesterol-lowering or blood pressure-lowering medications
- Fasting plasma triglycerides ≥ 4.0 mmol/L
- Medical history of diabetes mellitus, fasting plasma glucose ≥ 7.0 mmol/L or use of insulin or oral medication to control blood sugar
- Medical history of gastrointestinal disease, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use within the past 6 weeks
- Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis)
- Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥ 1.5 times the upper limit of normal (ULN))
- Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN)
- Active treatment for any type of cancer within 1 year prior to study start
- Major surgery within the last 3 months
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
- Unstable body weight (defined as > 5% change in 3 months) or actively participating in a weight loss program
- Tobacco and/or nicotine replacement use, current or within the last 3 months
- Taking medication (prescription or non-prescription) or dietary supplements (pre/probiotics, vitamins, minerals, fats, herbals) known to affect blood lipids, with the exception of stable doses of thyroxine and oral contraceptive agents
- Any food allergy, aversion or unwillingness to eat wheat or flax
- Daily consumption of flax containing products in the past month
- Regular intake of > 2 alcoholic drinks per day. Standard drink (13.6 g alcohol)= Beer (5% alcohol) 360 mL (12 fl.oz); Spirits (40% alcohol) 45 mL (1.5 fl.oz); wine (12% alcohol) 150 mL (5 fl.oz)
- Participation in another clinical trial, current or in the past 4 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 20g ground flaxseed per day muffin consume 1 muffin containing 20g ground flaxseed every day for 4 weeks 30g ground flaxseed per day muffin consume 1 muffin containing 30g ground flaxseed every day for 4 weeks 0g ground flaxseed per day muffin consume 1 muffin containing 0g ground flaxseed every day for 4 weeks
- Primary Outcome Measures
Name Time Method lipid profile 4 weeks plasma total cholesterol, HDL, LDL and triglycerides
- Secondary Outcome Measures
Name Time Method blood pressure 4 weeks flax metabolites 4 weeks plasma enterolignans and phospholipid fatty acid composition
high sensitivity c-reactive protein (hsCRP) 4 weeks glucose 4 weeks
Trial Locations
- Locations (2)
Asper Clinical Research Institute
🇨🇦Winnipeg, Manitoba, Canada
Glycemic Index Laboratories Inc.
🇨🇦Toronto, Ontario, Canada